HAIC Combined With Durvalumab and Tremelimumab and Lenvatinib in uHCC

NCT06364007 | Recruiting Phase 2

• 1 other identifier: SLiu0401
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The treatment options for unresectable HCC have rapidly developed, and immunotherapy has shown significant survival benefits in hepatocellular carcinoma. The STRIDE regimen of Single Tremelimumab (high, priming 300-mg dose) Regular Interval Durvalumab (1500 mg every 4 weeks) improved OS vs sorafenib in pts with unresectable HCC. In Asian region, HAIC is applied for HCC patients who are not suitable for surgical resection or local ablation treatment. Retrospective studies suggested a potent antitumor effect and survival benefit of HAIC plus programmed death-1 inhibitor and Lenvatinib. This phase II study was aimed to evaluate the efficacy and safety of STRIDE plus lenvatinib, given concurrently with HAIC in pts with unresectable HCC.

Conditions

Hepatocellular Carcinoma

Keywords

HAIC; uHCC; immunotherapy

Outcome Measures

Primary Outcomes (1)

• ORR

  objective response rate

  about 1 year

Secondary Outcomes (4)

• PFS

  about 1.5 year

• OS

  about 3 year

• DCR

  about 1 year

• AE

  about 3 year

Study Arms (1)

Treating with a Designed Protocol

EXPERIMENTAL

Drug: HAIC+STRIDE+Len

Interventions

HAIC+STRIDE+Len DRUG

patients will be administrated with STRIDE plus lenvatinib (8 mg or 12 mg) once daily plus HAIC- modified FOLFOX (oxaliplatin, 85 mg/m2; leucovorin, 400 mg/m2; 5-fluorouracil bolus, 400 mg/m2 on day 1; 5-fluorouracil infusion, 2400 mg/m2 for 46 h).

Treating with a Designed Protocol

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 \~ 70 years old (including 70 years old), male and female;
• Patients with hepatohcellular carcinoma diagnosed clinically or confirmed by histology / cytology ;
• Patients with unresectable or metastatic hepatocellular carcinoma;
• No systematic treatment. Patients recieved previously systematic treatment and progressed can also be included in the group;
• Patients who underwent hepatectomy in the past should be R0 resection, and the tumor recurrence should be more than 6 months after operation;
• At least one assessable lesion (mRECIST criteria);
• Expected survival time ≥ 3 months;
• ECOG 0 \~ 1;
• Child Pugh ≤ 7;
• Be able to cooperate to observe adverse events;
• Major organs are functioning normally:
• Hemoglobin ≥ 90 g / L;
• ANC ≥ 1.5 × 109/L；
• Platelet count ≥ 75 × 109/L；
• Albumin ≥ 28 g / L;

You may not qualify if:

• History of symptomatic congestive heart failure, unstable angina pectoris,
• Uncontrolled cardia arrhythmia
• History of hepatic encephalopathy
• Uncontrolled arterial hypertension
• Co-infection with HBV and HDV

Sponsors & Collaborators

• Sulai Liu: lead

Study Sites (1)

Hunan Provincial People's Hospital(The First Affiliated Hospital of Hunan Normal University)

Changsha, Hunan, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Chuang Peng, PhD

CONTACT

15200850489; pengchuangcn@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Hepatobiliary Surgical Department

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 12, 2024
• Study Start: March 3, 2024
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: April 12, 2024

Record last verified: 2024-04

Locations

CN (1)